FDA.reportPublic FDA data

AMSure® Pediatric Urine Collector

Primary DI
10704411008040
Brand
AMSure® Pediatric Urine Collector
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
AS408
Device description
AMSure® Pediatric Urine Collector
Published
2018-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EXIDevice, Paste-On For Incontinence, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXIDevice, Paste-On For Incontinence, SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30704411008044PackageGS150In Commercial Distribution
40704411008041PackageGS110In Commercial Distribution
10704411008040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070441100804430704411008044
4070441100804140704411008041
1070441100804010704411008040

GMDN Terms#

Term, Definition table
TermDefinition
Paediatric urine collection/analysis kit IVDA collection of devices intended to be used to collect and analyse a paediatric urine specimen for multiple clinical chemistry analytes (e.g., ketones, glucose and pH). It consists of a specimen collection undergarment (nappy or diaper) worn by the patient, and quantitative test strips for various clinical chemistry analytes. Results are analysed visually or with dedicated interpretive software (not included). It can be used at home by a caregiver and at the point-of-care by a healthcare professional. This is a single-use device.

Regulatory Flags#

DUNS number
825673239
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10704411017080AMSure ® Hydrophilic Latex Foley Catheters1AS41012HC2026-05-15
10704411017097AMSure ® Hydrophilic Latex Foley Catheters1AS41014HC2026-05-15
10704411017103AMSure ® Hydrophilic Latex Foley Catheters1AS41016HC2026-05-15
10704411017110AMSure ® Hydrophilic Latex Foley Catheters1AS41018HC2026-05-15
10704411017127AMSure ® Hydrophilic Latex Foley Catheters1AS41020HC2026-05-15
10704411017134AMSure ® Hydrophilic Latex Foley Catheters1AS41022HC2026-05-15
10704411017141AMSure ® Hydrophilic Latex Foley Catheters1AS41024HC2026-05-15
10704411017158AMSure ® Hydrophilic Latex Foley Catheters1AS42016HC2026-05-15
10704411017165AMSure ® Hydrophilic Latex Foley Catheters1AS42018HC2026-05-15
10704411017172AMSure ® Hydrophilic Latex Foley Catheters1AS42020HC2026-05-15
10704411017189AMSure ® Hydrophilic Latex Foley Catheters1AS42022HC2026-05-15
10704411017196AMSure ® Hydrophilic Latex Foley Catheters1AS42024HC2026-05-15
10704411021544AMSure® Cystoscopy/Bladder Irrigation Set1ABL4002026-04-10
10704411021551AMSure® Four Lead Bladder Irrigation Set1ABL4042026-04-10
10704411018834AMSure ® SUTURE REMOVAL KIT1SRT0012026-04-03
10704411018841AMSure ® Suture Removal Kit1SRT0022026-04-03
10704411018858AMSure ® Suture Removal Kit1SRT001Z2026-04-03
40704411007464AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS35302026-04-03
40704411007471AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS10102026-04-03
40704411007488AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS10032026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10687225793756PEDIATRIC URINE COLLECTORS, STERILEPRECISION DYNAMICS CORPORATIONEXI2023-06-20
10687225793596PEDIATRIC URINE COLLECTORS, STERILEPRECISION DYNAMICS CORPORATIONEXI2023-06-20
00616784428314Pediatric Urine CollectorDynarex CorporationEXI2021-06-21
10612479188713McKessonMCKESSON MEDICAL-SURGICAL INC.EXI2020-06-25
20612479188727McKessonMCKESSON MEDICAL-SURGICAL INC.EXI2020-06-25
10704411008057AMSure® Pediatric Urine CollectorAMSINO INTERNATIONAL, INC.EXI2018-06-01
10687225301852UR-Assure PRECISION DYNAMICS CORPORATIONEXI2017-10-25